8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DRAINAGE TUBE RESTRAINT/WOUND COVER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Sterngold Implant System Guided Drill 2.7mm x 12mm
FDA UDI
STERNGOLD DENTAL LLC·00841549118708·Used to generate the bore into the bone into wh...
EPI DENT TOOTHBRUSH
FDA 510(k)
FDA Class 1
·Dental
ADVANCED ISCHEMICA RECORDERS MODEL 2000 CASSETTE
FDA 510(k)
FDA Class 2
·Cardiovascular
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·November 16, 2010
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 1, 2014
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015